Vildagliptin and the Glucagon Response to Hypoglycemia in Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Study of the Effect of Vildagliptin on Glucagon Counterregulation Response During Hypoglycemia in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147276
• Other study ID #: Lund University Diabetes 002
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2010
• Last updated: September 21, 2012
• Start date: September 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2012
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The study examines whether DPP-4 inhibition by vildagliptin affects the glucagon counterregulatory response to hypoglycemia in type 1 diabetes.

Description:

Vildagliptin (50 mg BID) or placebo is given as add-on to insulin treatment for four weeks in patients with type 1 diabetes. Then, a hypoglycemic clamp (2.5 mmol/l glucose) is undertaken with the determination of glucagon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Age >18 years

• HbA1c 6.5-8,5%

Exclusion Criteria:

• Pregnancy

• Lactation

• Acute infection

• Liver disease

• Treatment with cortisol

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• Vildagliptin
Vildagliptin (50 mg BID) in four weeks

Locations

Country	Name	City	State
Sweden	Department of Clinical Sciences Lund, Lund University	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon response to hypoglycemia	Change in glucagon from before hypoglycemic clamp until after 45 min	45 min	No
Secondary	Catecholamine response to hypoglycemic	Change in catecholamines from before hypolycemic clamp to 45 min	45 min	No